The Recall Desk

Manufacturer

Siemens Healthcare Diagnostics, Inc.

667 recalls in our database name Siemens Healthcare Diagnostics, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
667
Critical
5
Severe
12
Most recent
2026-08-26

Of the 667 recalls from Siemens Healthcare Diagnostics, Inc. we have scored against our rubric, 5 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (2%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

276–300 of 667

  • ModerateFDA (Devices)·Z-0194-2019·2018-10-24

    Siemens Atellica Analyzer Software Recall for Diagnostic Errors

    Siemens is recalling Atellica Solution software version 1.13 and lower due to five behavioral issues that may cause incorrect test results or sample handling errors.

    Product
    Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0190-2019·2018-10-24

    Siemens Atellica Sample Handler Software Recall for Diagnostic Errors

    Siemens Healthcare Diagnostics is recalling Atellica Sample Handler Connect software versions 1.13 and lower due to five behavioral issues that may cause incorrect sample processing or result reporting.

    Product
    Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0117-2019·2018-10-24

    Siemens Atellica IM CKMB Master Curve Material Recalled for Potential Bias

    Siemens Healthcare Diagnostics is recalling Atellica IM CKMB Master Curve Material due to a potential bias identified when compared to internal standards.

    Product
    Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0192-2019·2018-10-24

    Siemens Atellica IM 1300 Analyzer Software Recall for Behavioral Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers with software version 1.13 and lower due to five identified behavioral issues affecting reagent locks, barcode reading, and result reporting.

    Product
    Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2927-2018·2018-09-05

    Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Interference

    Siemens is recalling RAPIDPoint 405 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.

    Product
    RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolyt
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2928-2018·2018-09-05

    Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Hydroxocobalamin Interference

    Siemens recalls RAPIDPoint 500 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.

    Product
    RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2929-2018·2018-09-05

    Siemens RAPIDLab Blood Gas Analyzer Recalled for Hydroxocobalamin Interference

    Siemens Healthcare Diagnostics is recalling 138 RAPIDLab 1245 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.

    Product
    RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including tota
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2930-2018·2018-09-05

    Siemens RAPIDLab 1265 Blood Gas Analyzer Recalled for Hydroxocobalamin Interference

    Siemens is recalling 2,357 RAPIDLab 1265 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.

    Product
    RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including tot
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2437-2018·2018-07-25

    Siemens Dimension Vista MULTI 1 SDIL Diluent Recall for Defective Septum

    Siemens is recalling 197 units of Dimension Vista MULTI 1 SDIL diluent due to a potential defect in the vial cap septum that may cause inaccurate test results.

    Product
    Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Devices)·Z-2436-2018·2018-07-25

    Siemens Dimension Vista CTNI Sample Diluent Recalled for Defective Cap Septum

    Siemens Healthcare Diagnostics is recalling 1,446 units of Dimension Vista CTNI Sample Diluent because a defective cap septum may cause erroneously elevated test results.

    Product
    Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Devices)·Z-2438-2018·2018-07-25

    Siemens Dimension Vista MULTI 2 SDIL Diluent Recall for Defective Septum

    Siemens is recalling 1,195 units of Dimension Vista MULTI 2 SDIL diluent because a defective septum may cause erroneously elevated test results.

    Product
    Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2182-2018·2018-06-20

    Siemens Gentamicin Reagent Cartridge Recall Due to Low-End Inaccuracy

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Gentamicin Flex reagent cartridges because they may produce inaccurate results at low concentrations.

    Product
    Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and 17312BB.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2181-2018·2018-06-20

    Siemens Recalls Dimension Gentamicin Flex Reagent Cartridges Due to Inaccuracy

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Gentamicin Flex reagent cartridges because they may produce inaccurate test results at the low end of the measurement range.

    Product
    Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2053-2018·2018-06-13

    Siemens ADVIA Centaur BNP Assay Recalled for Potential Analyzer Malfunction

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur BNP assays because they may cause analyzer malfunction or reduced dilution recovery when used with specific diluents.

    Product
    ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-2062-2018·2018-06-13

    Siemens ADVIA Chemistry Urea Nitrogen Reagent Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Urea Nitrogen Reagent due to increased calibration failures that prevent the system from generating results.

    Product
    ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2054-2018·2018-06-13

    Siemens ADVIA Centaur TSH3-Ultra Assay Recalled for Analyzer Compatibility Issues

    Siemens is recalling specific lots of ADVIA Centaur TSH3-Ultra assays because they may cause reduced dilution recovery or inoperability when used with Multi-Diluent 15 on certain analyzers.

    Product
    ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1946-2018·2018-06-06

    Syva EMIT 2000 Theophylline Assay Recalled for Increased Imprecision

    Siemens Healthcare Diagnostics is recalling Lot J1 of the Syva EMIT 2000 Theophylline Assay because it may show increased imprecision when used with a Beckman AU Clinical Chemistry System.

    Product
    Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1661-2018·2018-05-16

    Siemens Tacrolimus Assay Recalled for Interference with Sulfasalazine and Sulfapyridine

    Siemens Healthcare Diagnostics is recalling the Syva Emit 2000 Tacrolimus Assay because it may produce inaccurate results when patients take sulfasalazine or sulfapyridine.

    Product
    Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1684-2018·2018-05-16

    Siemens Recalls Immulite Assays Due to Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling certain IMMULITE assays because the instructions for use do not list the biotin concentration that causes interference, posing a risk of inaccurate test results.

    Product
    IMMULITE ¿ /IMMULITE ¿ 1000 TG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1685-2018·2018-05-16

    Siemens Recalls IMMULITE Assays Due to Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling specific IMMULITE assay kits because the user instructions fail to list the biotin concentration levels that cause test interference. This omission may lead to inaccurate diagnostic results for patients taking biotin supplements.

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi TG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1683-2018·2018-05-16

    Siemens Recalls IMMULITE Assays Due to Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling specific IMMULITE assay lots because the instructions fail to list biotin interference concentrations, potentially causing inaccurate test results.

    Product
    IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1648-2018·2018-05-16

    Siemens ADVIA Salicylate Reagent Recalled for Potential Test Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Salicylate reagent chemistry assays because various blood, urine, or cerebrospinal fluid assays may interfere with sulfasalazine and sulfapyridine, causing falsely elevated or depressed salicylate results.

    Product
    ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1662-2018·2018-05-16

    Siemens Syva Emit 2000 Sirolimus Assay Recalled for Interference

    Siemens Healthcare Diagnostics is recalling the Syva Emit 2000 Sirolimus Assay because it may produce inaccurate results when measuring patients taking sulfasalazine or sulfapyridine.

    Product
    Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1650-2018·2018-05-16

    Siemens Dimension ALTI Assay Recalled for Drug Interference

    Siemens is recalling Dimension ALTI assays because they may produce inaccurate results when patients take sulfasalazine or sulfapyridine.

    Product
    Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1672-2018·2018-05-16

    Siemens Recalls Dimension Vista MMB Reagent Cartridges Due to Biotin Interference

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridges because the instructions for use do not list the biotin concentration that causes interference.

    Product
    Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge
    Category
    Medical Device
    Distribution
    Distributed nationwide
Siemens Healthcare Diagnostics, Inc. recalls · The Recall Desk